The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for E-z Prep(r) Tray With Hibiclens(r).
| Device ID | K935483 |
| 510k Number | K935483 |
| Device Name: | E-Z PREP(R) TRAY WITH HIBICLENS(R) |
| Classification | General Surgery Tray |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Marcia C Leatham |
| Correspondent | Marcia C Leatham BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-15 |
| Decision Date | 1994-02-09 |